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Temozolomide and Radiation Therapy With or Without Vatalanib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00128700
First received: August 8, 2005
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vatalanib may stop the growth of tumor cells by blocking blood flow to the tumor. Giving temozolomide and radiation therapy together with vatalanib may kill more tumor cells.

PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of vatalanib when given together with temozolomide and radiation therapy and to see how well they work in treating patients with newly diagnosed glioblastoma multiforme.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: temozolomide
Drug: vatalanib
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study on Concomitant and Adjuvant Temozolomide and Radiotherapy With or Without PTK787/ZK222584 in Newly Diagnosed GBM

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Dose-limiting toxicity and maximum tolerated dose of vatalanib as determined by CTCAE v3.0 during phase I [ Designated as safety issue: Yes ]
  • Progression-free survival at 6 months during phase II [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Severe toxic events as assessed by CTCAE v3.0 at weeks 3 and 6 (concomitant treatment), weeks 2 and 4 after radiotherapy, before each course of adjuvant treatment, monthly during maintenance treatment, and every 3 months during follow-up in phase II [ Designated as safety issue: Yes ]
  • Overall survival at 1 year during phase II [ Designated as safety issue: No ]
  • Correlation of angiogenesis and hypoxia markers expression and O-6-methylguanine DNA methyltransferase (MGMT) methylation status with clinical outcome during phase II [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2005
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed glioblastoma multiforme

    • Newly diagnosed disease
  • Deemed to be amenable to concurrent and adjuvant temozolomide treatment by the principal investigator

PATIENT CHARACTERISTICS:

Age

  • 18 to 69

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase < 2.5 times ULN
  • ALT and AST < 2.5 times ULN

Renal

  • Creatinine ≤ 1.7 mg/dL

Cardiovascular

  • Cardiac function clinically normal
  • 12-lead ECG normal
  • No ischemic heart disease within the past 6 months
  • No uncontrolled cardiac arrhythmia
  • No uncontrolled hypertension
  • No history of stroke
  • No history of congenital long QT syndrome
  • QTc interval ≤ 450 msec for males or ≤ 470 msec for females by 12-lead ECG

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy except adequately treated basal cell or squamous cell skin cancer or cone biopsied carcinoma in situ of the cervix
  • No active uncontrolled infection
  • No other unstable systemic disease
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance or follow-up schedule

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior anti-vascular endothelial growth factor therapy

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Concurrent corticosteroids allowed provided the patient is on stable or decreasing doses for ≥ 2 weeks before study entry

Radiotherapy

  • No prior radiotherapy

Surgery

  • More than 8 days, but < 6 weeks, since prior surgery or biopsy

Other

  • No prior randomization on this study
  • No concurrent warfarin, warfarin-derived drugs, or similar anticoagulants
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  • No concurrent enzyme inducing antiepileptic drugs, including any of the following:

    • Carbamazepine
    • Fosphenytoin
    • Oxcarbazepine
    • Phenobarbital
    • Phenytoin
    • Primidone
  • No concurrent grapefruit or grapefruit juice
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00128700

Locations
Belgium
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Germany
Klinikum der Universitaet Regensburg
Regensburg, Germany, D-93053
Italy
Azienda Ospedaliera di Padova
Padova, Italy, 35128
Netherlands
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, Netherlands, 3075 EA
Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Alba A. Brandes, MD Azienda Ospedaliera di Padova
  More Information

Additional Information:
Publications:
Brandes AA, Stupp R, Hau P, et al.: EORTC Study 26041-22041: phase I/II study on concomitant and adjuvant temozolomide (TMZ) and radiotherapy (RT) with or without PTK787/ZK222584 (PTK/ZK) in newly diagnosed glioblastoma: results of a phase I trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-2026, 2007.

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00128700     History of Changes
Other Study ID Numbers: EORTC-26041-22041, EORTC-26041, EORTC-22041, EUDRACT-2004-003896-35
Study First Received: August 8, 2005
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult glioblastoma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Central Nervous System Neoplasms
Glioblastoma
Nervous System Neoplasms
Astrocytoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Neuroectodermal Tumors
Temozolomide
Vatalanib
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014